Court tells U.S. to lift limits on some 'Morning-after' pills
NEW YORK (AP) -- A federal appeals court Wednesday ordered that some types of emergency contraceptives, including one of the leading brands, be made available for now to women of all ages without a prescription, adding another layer of confusion to a complex and intensely political fight over the drug's availability.
In a brief ruling, the 2nd U.S. Circuit Court of Appeals ordered that the federal government lift all age and sales restrictions for two-pill versions of emergency contraceptives until the court finally rules on an appeal by the federal government, which is trying to limit the drug's over-the-counter availability.
Several two-pill versions of the drug are available without a prescription only to women 17 and older. In April, a federal district judge ruled that all versions of the so-called morning-after contraceptive be made available over the counter to all ages. The Obama administration appealed that ruling and asked that the judge's order be postponed until the appeals court rendered a final judgment this year. Court documents indicate that is likely to be in late August at the earliest.
The appeals court's interim ruling Wednesday does not lift all restrictions for Plan B One-Step, the one-pill version of the same drug. As a result of a decision by the Food and Drug Administration last month, that pill is available without a prescription for girls ages 15 and older, and purchasers are required to show identification to verify their age.
In Washington, officials with the FDA, the Health and Human Services Department and the Justice Department had no immediate comment, saying they were reviewing Wednesday's decision.
Both the one-pill and two-pill emergency contraceptives involve the same ingredient, the hormone levonorgestrel. But in recent decisions, the distinction between the two versions has been invoked primarily for legal or technical reasons.
The appeals court Wednesday did not explain why it permitted two-pill versions to be sold over the counter but not any one-pill versions. However, the original emergency contraception lawsuit, filed nearly a decade ago, referred to two-pill versions because there were no one-pill versions at the time. As a result, legal experts said, the appeals court might have decided in its order Wednesday that the government had less of a chance of succeeding in its appeal on the issue of two-pill versions than on the newer one-pill drugs.
The issue of emergency contraception is fraught with political sensitivities for the Obama administration. Conservative groups object to the drug itself, arguing that it might encourage young people to have unprotected sex. Some anti-abortion groups continue to contend that the drug is tantamount to an abortion pill, despite strong scientific evidence that the pill only prevents fertilization and does not act after an egg is fertilized.
Scientists have long argued against the need for any restrictions on the pill's sale, saying that studies show it is safer than many common over-the-counter drugs, including acetaminophen. And women's rights groups have advocated for the drug as a safe option for women in an emergency.
Supporters of lifting all restrictions note that most people who use the drug are not adolescents but that having any age limits at all requires pharmacies to make the pills more difficult to access for everyone, since government-issued picture identification is needed, and some people do not have such identification or might not have it readily available.
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In December 2011, as President Barack Obama was running for re-election, his secretary of health and human services, Kathleen Sebelius, took the unprecedented step of overruling an FDA plan to lift all age restrictions. Sebelius said she was concerned that there were not enough studies to prove that the drug was safe for girls as young as 11. Obama supported her decision, saying that as a father of young girls, the idea of making the drug available to them without a prescription made him uncomfortable.
The administration sought to strike a balance in May, supporting a change that made Plan B One-Step available to girl ages 15 and older without a prescription and directed drugstores to sell that pill openly, rather than locking it up behind a counter.
The FDA said it had restricted its decision to Plan B One-Step because the manufacturer, Teva Pharmaceuticals, filed an amended application to lower the age of availability to 15. The FDA also said that more studies would be required to show that girls younger than 17 could understand how to take two pills instead of just one.
The next day, the government appealed the broader federal court order, issued in April by Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York, who accused the government of placing politics ahead of science. The judge issued a similarly scathing response to the government's appeal, singling out what he called the "bad-faith, politically motivated decision of Secretary Sebelius, who lacks any medical or scientific expertise."